Analysis on approval and declaration of new Chinese medicines from 2016 to 2022
10.3760/cma.j.cn115398-20230531-00376
- VernacularTitle:2016－2022年中药新药批准及受理情况分析
- Author:
Xuezhen LI
1
;
Lishi CHEN
;
Xiating PING
;
Xiang ZHOU
Author Information
1. 浙江康恩贝制药股份有限公司药品研发中心 浙江省中药制药技术重点实验室，杭州 310052
- Keywords:
New drug research and development (TCD);
Review and approval;
Marketing authorization;
Investigational new drug;
New drug application;
Data analysis
- From:
International Journal of Traditional Chinese Medicine
2024;46(4):519-525
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To discuss and analyze the current situation of the application and approval of new Chinese medicine in China; To provide a reference for the research and development of new Chinese medicines in the future.Methods:The drug registration data were retrieved from Xanda database from January 1, 2016 to December 31, 2022, and the information of new approval and application of new Chinese medicines during this periods was systematically organized from the aspects of the number of registered varieties, registration categories, therapeutic areas, prescription sources, dosage form distribution, development cycle, clinical research and control drugs.Results:From 2016 to 2022, the total number of application for new Chinese medicines was 265. The number of registration classification 1.1 of new compound drugs was the largest. The dosage forms of new drugs were mainly granules, capsules, and tablets. Indications mainly focused on respiratory, neuropsychiatric, digestion and cardio-cerebrovascular diseases, etc. From 2016 to 2022, the total number of approval for new Chinese medicines was 29, of these, 19 from 2021 to 2022. The number of registration classification 1.1 of new Chinese medicines was the largest. The treatment fields are mainly respiratory system, gynecology and neuropsychiatric diseases, etc. The dosage forms of new drugs were mainly granules, capsules, and tablets. The number of drugs in prescriptions was 6-15. High-frequency drugs included Glycyrrhizae Radix et Rhizoma, Ephedrae Herba, Scutellariae Radix, Pinelliae Rhizoma, Poria and Gypsum Fibrosum. Phase Ⅱ and phase Ⅲ of the clinical trials had the largest number. The development period was approximately between 10-20 years. The most prescription source of new drugs was clinical experienced prescriptions and hospital pharmaceutics.Conclusion:The results show that China has been gradually building-up a relatively complete ecosystem for research and development of new Chinese medicines, helping to develop more high-quality Chinese medicines.
